(22 days)
The Standard Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm). The Teddy Bear Standard Thermometer is intended for professional and over-the-counter use. A pediatric model will be available. The plastic end of the thermometer has a molded Teddy Bear.
Electronic Thermometer
The provided document is a 510(k) summary for the "Standard Thermometer" by Global Treasures Industrial, Inc. It details the product, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed performance study results, acceptance criteria, or the specific information required to answer all the questions comprehensively.
Based on the available information, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not present in the provided 510(k) summary. A 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria as would be found in a full performance report. It states: "The Standard Thermometer measures patient body temperature in approx. 60 seconds. The thermometer is programmed to display the current body temperature. The temperature detected is graduated on 0.1ºF intervals, reading a range of 90.0ºF. The ambient temperature environment in which the device is intended for use is 60.8°-104°F (95% Relative Humidity)." This describes characteristics but not acceptance criteria for a performance study.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not present in the provided 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not present in the provided 510(k) summary. This type of information is typically relevant for studies involving subjective interpretations (like medical imaging), which is not directly applicable to a digital thermometer's performance testing where ground truth would be established by highly accurate reference measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present in the provided 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This question is not applicable to a thermometer. MRMC studies are used for evaluating diagnostic devices that rely on human interpretation, often with AI assistance, which is not the function of a standard electronic thermometer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the provided 510(k) summary. For a thermometer, "standalone performance" generally refers to the device's accuracy and precision as measured against a known standard, which would typically be part of a performance study, but the details of such a study are not included here. The summary focuses on comparing it to another thermometer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present in the provided 510(k) summary. For a thermometer, the "ground truth" would typically be established by a highly accurate, calibrated reference thermometer.
8. The sample size for the training set:
This information is not present in the provided 510(k) summary. This question is typically relevant for machine learning or AI-based devices, which a standard digital thermometer is not.
9. How the ground truth for the training set was established:
This information is not present in the provided 510(k) summary. As above, this question is typically relevant for machine learning or AI-based devices.
In summary: The provided document is a regulatory submission focused on demonstrating substantial equivalence. It lacks the detailed technical performance study information, acceptance criteria, and ground truth establishment methods that would be found in a comprehensive device performance report.
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510k Submission Global Treasures Industrial, Inc. Standard Thermometer
510 (K) SUMMARY
Date of Summary
January 26, 2003
Product Name:
Standard Thermometer
Manufacturer:
Global Treasures Industrial Ltd. Nan Fung Ind. Cit 18 Tin Hau Road Tuen Mun N.T. , HK
Correspondent:
Fran White MDC Associates 163 Cabot Street Beverly, MA 01915
Substantially Equivalent Device:
Product: GT010706 Digital Thermometer (K021052) Manufactured by: Global Treasures Industrial, Inc.
Product Description:
Electronic Thermometer
Intended Use:
The Standard Thermometer is an electronic thermometer to measure patient body temperature orally, rectally or axilliary (under arm).
The Teddy Bear Standard Thermometer is intended for professional and over-the-counter use. A pediatric model will be available. The plastic end of the thermometer has a molded Teddy Bear.
Performance Characteristics:
The Standard Thermometer measures patient body temperature in approx. 60 seconds. The thermometer is programmed to display the current body temperature. The temperature detected is graduated on 0.1ºF intervals, reading a range of 90.0ºF. The ambient temperature environment in which the device is intended for use is 60.8°-104°F (95% Relative Humidity).
Conclusion:
The Standard Thermometer substantially equivalent to the electronic thermometer manufactured by Global Treasures, GT010706 Digital Thermometer (K021052).
Sponsor Global Treasures, Industrial, Inc. Nan Fung Ind. Cit 18 Tin Hau Road Tuen Mun, N.T., HK
MAR 2 5 2003
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized design of three human profiles facing to the right, stacked on top of each other. The words "HUMAN SERVICES - USA" are arranged in a circular fashion at the top of the logo, and the word "DEPARTMENT" is at the bottom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 5 2003
Global Treasure Industries Limited C/O Ms. Fran White MDC Associates 163 Cabot Street Beverly, Massachusetts 01915
Re: K030658
Trade/Device Name: Standard Thermometer Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 25, 2003 Received: March 3, 2003
Dear Ms. White:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. White
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Ranses
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510k Submission Global Treasures Industrial, Inc. Standard Thermometer
510(k) Number:
Standard Thermometer Device Name:
Indication for Use:
The Standard Thermometer is an electronic thermometer to measure patient temperature. Targeted users include professional and over-the-counter users.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use (Optional Format 1-2-96)
Patricia Cucurite
Division Sian-C tivision of Anesthesiology. General Hospital. Infection Control. Denta
510(k) Number: K030658
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.